Honoring George D. Richards on Tuesday, July 19, 2016

George D. Richards (1919-2016)

It is with a heavy heart that we are having to announce that our Founder and Chairman of Capital Wholesale Drug Co., George D. Richards (GD) passed away Thursday morning. He was surrounded by family at his home in Upper Arlington, Ohio.

As to commemorate and celebrate the 97 years we had with George, Capital Wholesale Drug will be closed this upcoming Tuesday, July 19th.

Services will be held that day at Schoedinger’s Funeral Home, 1740 Zollinger Road, Columbus, OH 43221 at 11am with a reception to follow immediately after the service. All are welcome to attend this public service.

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Title II of the Drug Quality and Security Act of 2013

The Drug Quality and Security Act (DQSA), was signed into law by President Obama on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act, outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. 

Ten years after enactment, the system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain. The new system will:

  • enable verification of the legitimacy of the drug product identifier down to the package level;
  • enhance detection and notification of illegitimate products in the drug supply chain; and
  • facilitate more efficient recalls of drug products.

Drug manufacturers, wholesale drug distributors, repackagers, and many dispensers (primarily pharmacies) will be called on to work in cooperation with FDA to develop the new system over the next 10 years.

—Learn More—

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Prasco Acquires Teva’s Authorized Generic of Adderall XR

Prasco Laboratories (“Prasco”) today announced that it has entered into agreements with Teva Pharmaceutical Industries Ltd. (Teva) and Shire LLC, an indirect subsidiary of Shire plc, to acquire the rights to distribute Dextroamphetamine Saccharate, Amphetamine

Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended Release Capsules, CII, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg, the Authorized Generic (AG) version of Adderall XR® Extended Release Capsules, CII. As a result of this acquisition, Prasco will market an AG version of Adderall XR Capsules, CII in the United States that is therapeutically equivalent and substitutable for prescriptions written for Adderall XR, a CNS stimulant that is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). Continue reading

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Vermont first state to require drug makers to justify price hikes

By ED SILVERMAN @Pharmalot

Despite opposition from the pharmaceutical industry, Vermont late last week became the first state in the country to require drug makers to justify price hikes for medicines.

 

The law is part of a wave of state legislation that comes in response to growing concern over the rising cost of prescription drugs. Around the country, lawmakers have been introducing bills in hopes of forcing drug makers to either disclose costs or explain pricing. These demands reflect industry arguments that rising prices reflect rising R&D costs.“This bill is about accountability,” Vermont Governor Peter Shumlin said in a statement. Continue reading
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FDA approves first buprenorphine implant for treatment of opioid dependence

Expanded use and availability of medication-assisted treatment is a top priority of federal effort to combat opioid epidemic

The U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.

Until today, buprenorphine for the treatment of opioid dependence was only approved as a pill or a film placed under the tongue or on the inside of a person’s cheek until it dissolved. While effective, a pill or film may be lost, forgotten or stolen. However, as an implant, Probuphine provides a new treatment option for people in recovery who may value the unique benefits of a six-month implant compared to other forms of buprenorphine, such as the possibility of improved patient convenience from not needing to take medication on a daily basis. An independent FDA advisory committee supported the approval of Probuphine in a meeting held earlier this year. Continue reading

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FDA Advising on side effects of Antibacterial Drugs

The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolone should be reserved for those who do not have alternative treatment options.

An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.

As a result, we are requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. We are continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

 

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They call it the poor man’s methadone.

The epidemic of opioid addiction sweeping the country has led to another form of drug abuse that few experts saw coming: Addicts who cannot lay hands on painkillers are instead turning to Imodium and other anti-diarrhea medications. The active ingredient, loperamide, offers a cheap high if it is consumed in extraordinary amounts. But in addition to being uncomfortably constipating, it can be toxic, even deadly, to the heart. A report published online in Annals of Emergency Medicine recently described two deaths in New York after loperamide abuse. And overdoses have been linked to deaths or life-threatening irregular heartbeats in at least a dozen other cases in five states in the last 18 months.  See link for more: http://www.nytimes.com/2016/05/11/health/imodium-opioid-addiction.html?_r=0

 

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Anticipated Ship Dates

Amox/Clav ES 600 – May/June

Amox/Clav XR – Temporarily Discontinued

Anagrelide .5mg – 6/5

Apap W/Cod #3 – 5/20

Carbidopa/Levo – 6/17

Cimetidine – 6/10

Flurbiprofen – 6/24

Griseofulvin 125mg susp – 7/29

Guaifenesin ER 600mg – July

Hydralazine – 6/10

Hydroxocobalamin – 6/10

Hydroxyzine – To Be Determined

Midodrine – To Be Determined

Moex/HCTZ – 5/23

Prochlorperazine—6/30

Sumatriptan NS -  To Be Determined

Ventolin 8gm – Late May

Zenatane – 5/23

 

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Could OTC Allergy Drug help Multiple Sclerosis Patients?

A generic drug for allergy symptoms showed signs that it may help patients with multiple sclerosis rebuild their eye nerves, offering a possible over-the-counter path to treat a disease now addressed with therapies from companies such as Biogen Inc.  Patients on the drug, called clemastine fumarate, sent signals between the eyes and the brain faster than those on placebo in a mid-stage study, according to a statement Tuesday from the American Academy of Neurology. That suggests the drug may be helping repair nerves that are damaged in some patients with multiple sclerosis.                                                                                                                                                                                                                                           http://www.bloomberg.com/news/articles/2016-04-12/generic-drug-helps-multiple-sclerosis-damage-in-mid-stage-trial

 

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FDA is requiring labeling changes regarding the recommendations for metformin

FDA is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally. FDA was asked to review numerous medical studies regarding the safety of metformin use in patients with mild to moderate impairment in kidney function, and to change the measure of kidney function in the metformin drug labeling that is used to determine whether a patient can receive metformin.

FDA concluded, from the review of studies published in the medical literature, that           metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function. FDA is requiring changes to the metformin labeling to reflect this new information and provide specific recommendations on the drug’s use in patients with mild to moderate kidney impairment.

Please see link for additional information: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm494829.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

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